Efficacy Study of GLYC-101 to Evaluate Outcomes After Laser Ablation

NCT00792688 | Completed Phase 2 Results

• 1 other identifier: GLYC-101-1b
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objectives of this study are to evaluate safety and efficacy of topically applied Glucoprime gel (GLYC-101, 0.1% and GLYC-101, 1.0%) in promoting wound healing in cosmetic surgery patients undergoing Carbon Dioxide Laser Skin Resurfacing (CO2 LSR) of the lower eyelids. The study will observe the effects of the topical agent over the course of 1 month following the initial treatment.

Conditions

Wounds

Keywords

burn wounds; wound healing

Outcome Measures

Primary Outcomes (1)

• Time to Complete Wound Closure (Epithelialization)

  Subjects were evaluated daily from the time of the laser procedure and initial application of test article until the subject's wounds reached 100% epithelialization. Efficacy was assessed based on the time to complete epithelialization in terms of the number of days from Day 1 (day of laser ablation) to the day on which complete epithelialization was observed.

  Over the course of 1 month following the initial treatment.

Secondary Outcomes (1)

• Cosmesis/11-point Likert Scale

  At 1 month following the initial treatment.

Study Arms (3)

1

EXPERIMENTAL

GLYC-101 Gel, 0.1% on one eyelid and Placebo Gel on the other eyelid

Drug: GLYC-101 Gel (0.1%); Drug: GLYC-101 Placebo

2

EXPERIMENTAL

GLYC-101 Gel, 1.0% on one eyelid and Placebo Gel on the other eyelid

Drug: GLYC-101 Gel (1.0%); Drug: GLYC-101 Placebo

3

EXPERIMENTAL

GLYC-101 Gel, 0.1% on one eyelid and GLYC-101 Gel, 1.0% on the other eyelid

Drug: GLYC-101 Gel (0.1%); Drug: GLYC-101 Gel (1.0%)

Interventions

GLYC-101 Gel (0.1%) DRUG

Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5.

1; 3

GLYC-101 Gel (1.0%) DRUG

Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5.

2; 3

GLYC-101 Placebo DRUG

Topical administration to the laser-ablated area on days 1 (day of laser ablation), 2, 3, 4, and 5.

1; 2

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female healthy volunteer subjects, between 25 and 70 years of age, giving informed consent for facial laser ablation of the lower eyelid areas for the purpose of wrinkle removal.
• Lower eyelid skin is free of any irritation, scarring or dermatologic conditions which might interfere with the study.
• Willing and able to participate in the study and follow all study directions.
• Able to read, understand and sign the consent form prior to any study related procedures.

You may not qualify if:

• Female subjects who are pregnant, nursing, or planning a pregnancy during the course of the study, as determined by the interview and a urine pregnancy test.
• Presence of irritation or dermatologic skin conditions in the lower eyelid area.
• Known allergies to materials within the test formulations (i.e., yeast and/or yeast products).
• Use of topical or systemic drugs (corticosteroids, retinoids, immune modulators, immune suppressants, drugs with potential for contact dermatitis, drugs with potential for skin discoloration) that may have an effect on wound healing or may impact skin pigmentation.
• A history, upon wounding, of developing thickened scars, keloids, or excessive pigment change.
• An unstable or severe inter-current medical condition that, in the opinion of the investigator, might interfere with interpretation of study results or render the subject at high risk for treatment complications.
• Use of any investigational medication or device for any indication within 30 days of screening.

Sponsors & Collaborators

• TR Therapeutics: lead

Study Sites (1)

CLINICAL TESTING CENTER of BEVERLY HILLS

Beverly Hills, California, 90210, United States

Location

MeSH Terms

Conditions

Wounds and Injuries; Burns

Results Point of Contact

• Title: Dr. Reinhard Koenig, CEO
• Organization: Glycotex, Inc.

Reinhard.Koenig@glycotexinc.com

301-670-2825

Study Officials

• John Joseph, MD

  The Clinical Testing Center of Beverly Hills

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2008
• First Posted: November 18, 2008
• Study Start: October 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: October 28, 2021
• Results First Posted: July 25, 2011

Record last verified: 2021-10

Locations

US (1)